今天是:2019-06-18 星期二

经会阴激光消融(TPLA)治疗前列腺增生的有效性及安全性国际多中心临床研究:与经尿道电切术(TURP)对照、随机、开放临床试验
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注册号:

Registration number:

ChiCTR1900022739 

最近更新日期:

Date of Last Refreshed on:

2019-04-24 

注册时间:

Date of Registration:

2019-04-24 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

经会阴激光消融(TPLA)治疗前列腺增生的有效性及安全性国际多中心临床研究:与经尿道电切术(TURP)对照、随机、开放临床试验 

Public title:

The effectiveness and safety of transperineal percutaneous laser ablation (TPLA) for treating benign prostatic hyperplasia (BPH): An International multicentre clinical study: compared with transurethral resection of the prostate (TURP), randomized, open-label 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

经会阴激光消融(TPLA)治疗前列腺增生的有效性及安全性国际多中心临床研究:与经尿道电切术(TURP)对照、随机、开放临床试验 

Scientific title:

The effectiveness and safety of transperineal percutaneous laser ablation (TPLA) for treating benign prostatic hyperplasia (BPH): An International multicentre clinical study: compared with transurethral resection of the prostate (TURP), randomized, open-label 

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

孟哲颖 

研究负责人:

胡兵 、傅强 

Applicant:

Meng Zheying 

Study leader:

Hu Bing, Fu Qiang 

申请注册联系人电话:

Applicant telephone:

+86 18817821719 

研究负责人电话:

Study leader's telephone:

+86 18930173507 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

844166899@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

binghu_stephen@163.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

上海市徐汇区宜山路600号 

研究负责人通讯地址:

上海市徐汇区宜山路600号 

Applicant address:

600 Yishan Road, Xuhui District, Shanghai 

Study leader's address:

600 Yishan Road, Xuhui District, Shanghai 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

上海交通大学附属第六人民医院 

Applicant's institution:

Shanghai Jiaotong University Affiliated Sixth People's Hospital  

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

2018-034-(5) 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

上海市第六人民医院伦理委员会 

Name of the ethic committee:

Shanghai Sixth People's Hospital Independent Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-04-22 

伦理委员会联系人:

孙秀秀 

Contact Name of the ethic committee:

Sun Xiuxiu 

伦理委员会联系地址:

上海市徐汇区宜山路600号 

Contact Address of the ethic committee:

600 Yishan Road, Xuhui District, Shanghai 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

上海交通大学附属第六人民医院 

Primary sponsor:

Shanghai Jiaotong University Affiliated Sixth People's Hospital  

研究实施负责(组长)单位地址:

上海市徐汇区宜山路600号 

Primary sponsor's address:

600 Yishan Road, Xuhui District, Shanghai 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海交通大学附属第六人民医院

具体地址:

徐汇区宜山路600号

Institution
hospital:

Shanghai Jiaotong University Affiliated Sixth People's Hospital

Address:

600 Yishan Road, Xuhui District

经费或物资来源:

上海市重中之重临床医学中心和重点学科建设项目 

Source(s) of funding:

Shanghai top priority clinical medical center and key discipline construction project 

研究疾病:

前列腺增生 

Target disease:

benign prostatic hyperplasia 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

主要目的: 使用TURP作为对照,评估经直肠超声引导下TPLA是否能有效治疗BPH并改善BPH患者LUTS症状;TPLA安全性否存在优势。 次要目的: 使用TURP作为对照,评价TPLA治疗是否能改善BPH患者最大尿流率、生活质量评分QoL、排尿后残余尿量PVR。 与TURP比较,TPLA在治疗时间及住院时间方面等是否存在优势。 

Objectives of Study:

Primary objective: The TURP is used as the control group to evaluate whether TPLA guided by the transrectal ultrasound (TRUS) could treat BPH effectively and improve the LUTS of the BPH patients and to evaluate whether TPLA has an advantage in the incident rate of the postoperative complications. Secondary objective: 1) The TURP is used as the control group to evaluate whether TPLA guided by TRUS can improve the maximum urinary flow rate, patients Quality of Life (QoL) and post-urination residue. 2) To evaluate whether TPLA has advantages in terms of the operation time and hospitalization time when compared with TURP.  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

(1) 由于BPH导致下尿路症状(LUTS)就诊、药物治疗无效或由临床医生判断不适合药物治疗的患者; (2) 年龄≥ 50岁男性; (3) IPSS评分分级为中度及以上; (4) 30ml≤经直肠超声检查测算前列腺体积≤100ml; (5) 最大尿流率(Qmax) ≤15 mL/s; (6) 残余尿≥50ml。 

Inclusion criteria

(1) Patients with LUTS caused by BPH who are ineffective or unsuitable for medical treatment judged by the clinician; (2) Male aged over 50 years; (3) IPSS degree moderate or above; (4) 30ml ≤ the prostate volume measured by TRUS ≤ 100ml; (5) Qmax ≤ 15mL/s; (6) Post-urination residue ≥ 50ml. 

排除标准:

(1) 尿道狭窄患者; (2) 有过前列腺、膀胱或尿道手术史; (3) 因膀胱功能障碍导致排尿困难患者; (4) 有长期导尿管留置病史; (5) BPH以中叶增生为主者(膀胱内前列腺突出度IPP≥10mm);经腹膀胱超声发现膀胱结石或明显膀胱肿瘤; (6) 病理证实为前列腺癌患者;PSA≥4ng/ml且PSAD≥0.15 ng/ml2,排除由医疗操作因素导致者; (7) 患者有神经疾病,如多发性硬化症,帕金森氏病以及存在脊髓损伤病史; (8) 直肠术后或肛门封闭患者; (9) 严重凝血障碍或感染患者; (10) 正在参与或随机分组4周前参与另一项临床研究。 

Exclusion criteria:

(1) Urethral stenosis; (2) Previous prostate, bladder or urethral surgery; (3) Dysuria caused by bladder dysfunction; (4) History of long term indwelling catheter; (5) BPH with mainly medial lobe hyperplasia (Intravesical Prostate Projection ≥ 10mm); Transabdominal bladder ultrasonography revealed bladder calculi or obvious bladder tumor; (6) Prostate cancer patients proved by pathology; PSA > 4ng/ml and PSAD≥ 0.15 ng/ml2 and exclude the factor of iatrogenic injury; (7) Patients with known neurological disorders, e.g., multiple sclerosis, Parkinsons disease, or known history of spinal cord injury; (8) Post rectal surgery or patients with anal atresia; (9) Patients with severe coagulation disorders or with infection; (10) Patients are participating in another clinical study or have been enrolled in another clinical study 4 weeks before randomization. 

研究实施时间:

Study execute time:

From2019-05-01To 2021-05-01 

干预措施:

Interventions:

组别:

1

样本量:

70

Group:

1

Sample size:

干预措施:

经会阴激光消融术

干预措施代码:

01

Intervention:

transperineal percutaneous laser ablation

Intervention code:

组别:

2

样本量:

70

Group:

2

Sample size:

干预措施:

经尿道前列腺电切术

干预措施代码:

02

Intervention:

transurethral resection of the prostate, TURP

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海交通大学附属第六人民医院 

单位级别:

三级甲等 

Institution
hospital:

Shanghai Jiaotong University Affiliated Sixth People's Hospital  

Level of the institution:

Tertiary A 

国家:

意大利 

省(直辖市):

米兰 

市(区县):

 

Country:

Italy 

Province:

Milan 

City:

 

单位(医院):

Pesenti-Fenaroli Hospital, Milan, Italy 

单位级别:

三级甲等 

Institution
hospital:

Pesenti-Fenaroli Hospital, Milan, Italy  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国人民解放军总医院 

单位级别:

三级甲等 

Institution
hospital:

Chinese PLA General Hospital  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

广东 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

中山大学附属第三医院 

单位级别:

三级甲等 

Institution
hospital:

The Third Affiliated Hospital, Sun Yat-sen University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

浙江 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

浙江大学附属第一医院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital, Zhejiang University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

浙江 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

浙江大学医学院附属杭州市第一人民医院 

单位级别:

三级甲等 

Institution
hospital:

Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海交通大学医学院附属新华医院 

单位级别:

三级甲等 

Institution
hospital:

Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

同济大学附属第十人民医院 

单位级别:

三级甲等 

Institution
hospital:

Tenth People's Hospital of Tongji University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海中医药大学附属市中医医院 

单位级别:

三级甲等 

Institution
hospital:

Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Tradiional Chinese Medicine  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

江苏 

市(区县):

 

Country:

China 

Province:

Jiangsu 

City:

 

单位(医院):

南京医科大学第一附属医院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital with Nanjing Medical University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

山西 

市(区县):

 

Country:

China 

Province:

Shanxi 

City:

 

单位(医院):

山西医科大学附属肿瘤医院 

单位级别:

三级甲等 

Institution
hospital:

Shanxi Medical University Affiliated Tumor Hospital  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

福建 

市(区县):

 

Country:

China 

Province:

Fujian 

City:

 

单位(医院):

厦门市中医院 

单位级别:

三级甲等 

Institution
hospital:

Xiamen Hospital of Traditional Chinese Medicine  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

云南 

市(区县):

 

Country:

China 

Province:

Yunnan 

City:

 

单位(医院):

曲靖市第一人民医院 

单位级别:

三级甲等 

Institution
hospital:

Qujing First Hospital, Qujing Hospital Affilated to Kunming Medical University  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海交通大学附属第一人民医院 

单位级别:

三级甲等 

Institution
hospital:

Shanghai General Hospital  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

四川 

市(区县):

 

Country:

China 

Province:

Sichuan 

City:

 

单位(医院):

电子科技大学医学院附属肿瘤医院 

单位级别:

三级甲等 

Institution
hospital:

The Affiliated Cancer Hospital, School of Medicine, UESTC  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

云南 

市(区县):

 

Country:

China 

Province:

Yunnan 

City:

 

单位(医院):

云南省第二人民医院 

单位级别:

三级甲等 

Institution
hospital:

Yunnan Second People's Hospital  

Level of the institution:

Tertiary A 

国家:

瑞士 

省(直辖市):

日内瓦 

市(区县):

 

Country:

Switerzland 

Province:

Geneve 

City:

 

单位(医院):

Clinque La Colline, Geneve,Switerzland 

单位级别:

综合性私人诊所 

Institution
hospital:

Clinque La Colline, Geneve,Switerzland  

Level of the institution:

comprehensive private clinic 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海中医药大学附属第七人民医院 

单位级别:

三级甲等 

Institution
hospital:

Seventh People's Hospital of Shanghai University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

浙江 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

嘉兴市老年病医院 

单位级别:

二甲 

Institution
hospital:

Jiaxing Geriatric Hospital  

Level of the institution:

Secondary A 

测量指标:

Outcomes:

指标中文名:

术后3个月时IPSS评分相对基线时的改变量

指标类型:

主要指标 

Outcome:

Changes in IPSS relative to baseline levels at 3 months postoperatively

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Qmax [术后3个月、6个月、12个月]

指标类型:

次要指标 

Outcome:

Qmax [3 months, 6 months, 12 months after treatment]

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

残余尿 [术后3个月、6个月、12个月]

指标类型:

次要指标 

Outcome:

Residual urine [3 months, 6 months, 12 months after treatment]

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后3个月内并发症发生率

指标类型:

主要指标 

Outcome:

complication rate within 3 months after surgery

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

由研究者或其指定人员判定为具有临床意义的治疗后生命体征(心率、呼吸、血压)、ECG以及实验室检查(肝肾功能、血常规)的变化。

指标类型:

次要指标 

Outcome:

clinically significant post-treatment changes in vital signs (heart rate, respiration, blood pressure), ECG and laboratory tests (liver and kidney function, blood routine) determined by the investigator or his designee

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生活质量评分 [术后3个月、6个月、12个月]

指标类型:

次要指标 

Outcome:

Quality of life score [3 months, 6 months, 12 months after treatment]

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

欧洲五维健康量表评分EQ-5D [术后3个月、6个月、12个月]

指标类型:

次要指标 

Outcome:

European five-dimensional health scale score EQ-5D [3 months, 6 months after treatment]

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术中出血量;

指标类型:

次要指标 

Outcome:

intraoperative blood loss

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疼痛评分

指标类型:

次要指标 

Outcome:

VAS pain score

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

导尿管留置时间

指标类型:

次要指标 

Outcome:

postoperative urinary catheter retention time

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

手术成功率

指标类型:

次要指标 

Outcome:

surgical success rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液,

组织:

Sample Name:

blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

尿液

组织:

Sample Name:

urine

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 50 years
最大 Max age years

性别:

男性

Gender:

Male

随机方法(请说明由何人用什么方法产生随机序列):

由第三方人员用中央随机化系统

Randomization Procedure (please state who generates the random number sequence and by what method):

A central randomization system used by a third party.

盲法:

open-label

Blinding:

open-label

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

上传至公共数据库

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

Upload to a public database

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

EDC

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

EDC

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-04-24
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